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FDA 510(k)

PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS

K-Number: K954790 · 1996-01-16

ApplicantTulsa Dental Products, Ltd.
Decision Date1996-01-16
Product CodeDZA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Tulsa Dental Products, Ltd.. It received FDA 510(k) clearance on 1996-01-16 under 510(k) number K954790. The device is classified under product code DZA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS?

PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1996-01-16. The listed applicant is Tulsa Dental Products, Ltd.. The 510(k) number is K954790.

When did PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS receive FDA 510(k) clearance?

PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS received FDA 510(k) clearance on 1996-01-16, under 510(k) number K954790.

Who is the listed applicant for PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS?

The FDA 510(k) record lists Tulsa Dental Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS?

The FDA product code for PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS is DZA.

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Other records listing Tulsa Dental Products, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K970134THERMAPREP PLUS OVENK964174MINERAL TRIOXIDE AGGREGATE (MTA)K922931THERMAPOST ENDODONTIC ROOT CANAL POSTK933582PROFILE SERIES 29 FILESK910224THERMAPREPK900986THERMAFIL ENDODONTIC OBTURATOR

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Related Devices (Code: DZA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K984508SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MODW&H Dentalwerk Buermoos GmbHK962979S-53 INTRORAL DENTAL SYSTEMDel Medical Systems Corp.K914724ADA SHANK EXTENSIONImplant Corp. of AmericaK905418GATES GLIDDEN DRILLSThe Hygenic Corp.K901097FILLOCK REAMERIvoclar North America, Inc.K896149ANEST-EZE DENTAL DRILL RA#2Signature One Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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